Independent GxP consulting, validation, audit and data integrity expertise designed to help regulated organizations strengthen compliance and remain inspection-ready.
I have over 11 years of experience in the pharmaceutical industry, specializing in GxP audits, Computer System Validation (CSV), data integrity, and regulatory compliance. I provide independent third-party audits and gap assessments for pharmaceutical computerized systems and processes, helping organizations identify compliance gaps and improve their overall audit readiness. My experience includes auditing systems such as Waters Empower, DCS, Eurotherm Temperature & RH Monitoring Systems, and Document Management Systems, with a focus on 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity requirements. I also conduct vendor and supplier audits, computerized system audits, data integrity assessments, and validation documentation reviews. My approach is practical and risk-based, with clear audit observations, compliance assessments, and recommendations to support effective remediation and continuous improvement. I work closely with QA, QC, IT, Engineering, Manufacturing, and Validation teams to help organizations maintain compliant systems and stay prepared for customer and regulatory inspections.
Selected certifications and professional achievements supporting our expertise in quality, compliance, auditing and continuous improvement.
Whether you need an independent GxP audit, computerized system validation support, data integrity assessment or regulatory compliance guidance, let's discuss your requirements.
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